País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Diphtheria toxoid, Quantity: 4 IU/mL; Tetanus toxoid, Quantity: 40 IU/mL
Seqirus Pty Ltd
Diphtheria toxoid,Tetanus toxoid
Injection, suspension
Excipient Ingredients: water for injections; sodium hydroxide; aluminium hydroxide hydrate; sodium chloride
Intramuscular
1 x single dose syringe, 5 x single dose syringe
(S4) Prescription Only Medicine
Vaccination of children (greater than or equal to 5 years of age) and adults who have previously received at least 3 doses of a vaccine for primary immunisation against diphtheria and tetanus. ADT Booster is not intended for primary immunisation against diphtheria and tetanus. Use of ADT Booster should be scheduled in accordance with official national recommendations.
Visual Identification: suspension of white or grey particles in colourless or light yellow liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2006-12-11
1 ADT ™ BOOSTER _(ay-dee-tee boo-ster)_ DIPHTHERIA AND TETANUS VACCINE, ADSORBED CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ADT ™ BOOSTER. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child (of five years or older) having ADT ™ BOOSTER against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINE, TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET. You might need to read it again. WHAT ADT ™ BOOSTER IS USED FOR ADT ™ BOOSTER is a “combination” vaccine. It helps prevent TWO diseases, each caused by a different infection. The diseases are • diphtheria _and_ • tetanus. Both of these infections are serious and can be life-threatening. ADT ™ BOOSTER is used to vaccinate children (≥ 5 years of age) and adults who have previously received at least three doses of a vaccine for primary immunisation against diphtheria and tetanus. ADT ™ BOOSTER is not intended for primary immunisation against diphtheria and tetanus. ADT ™ BOOSTER is given as one ADDITIONAL dose (BOOSTER dose) with intervals according to national recommendations. _HOW ADT_ _™ _ _BOOSTER WORKS_ ADT ™ BOOSTER works by getting your body to produce its own protection against the two types of bacteria (germs). The germs are those that cause two different and serious infections • diphtheria _and_ • tetanus. The vaccine does not contain live germs and cannot give you these illnesses. After you have ADT ™ BOOSTER, your body makes substances called antibodies. These antibodies fight both the diphtheria and the tetanus germs. When you come into contact with these germs, your body is usually ready to destroy them. Most people who receive the booster dose (suitable only if in the past they have had the full primary course against diphtheria and tetanus) will Leer el documento completo
1 AUSTRALIAN PRODUCT INFORMATION – ADT™ BOOSTER (DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) (DIPHTHERIA AND TETANUS VACCINE)) – SUSPENSION FOR INJECTION 1 NAME OF THE MEDICINE Diphtheria and Tetanus toxoids (adsorbed) (Diphtheria and Tetanus Vaccine). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ADT ™ Booster is a suspension for intramuscular injection, containing aluminium-hydroxide-adsorbed diphtheria and tetanus toxoids. Each 0.5mL dose contains no less than 2 International Units (IU) of purified diphtheria toxoid and no less than 20 IU of purified tetanus toxoid. Each dose of ADT ™ Booster also contains the following excipients: aluminium hydroxide hydrate corresponding to 0.5 mg aluminium, sodium chloride (4 mg), sodium hydroxide q.s. to pH 7, and Water for Injections. The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product. 3 PHARMACEUTICAL FORM Suspension for intramuscular injection. The vaccine should appear as a suspension of white or grey particles in a colourless or light yellow liquid. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Vaccination of children ( ≥ 5 years of age) and adults who have previously received at least 3 doses of a vaccine for primary immunisation against diphtheria and tetanus. ADT ™ Booster is NOT intended for primary immunisation against diphtheria and tetanus. Use of ADT ™ Booster should be scheduled in accordance with official national recommendations. 4.2 D OSE AND METHOD OF ADMINISTRATION The dose of ADT™ Booster is 0.5 mL. Injections should be given by the intramuscular route. For details of recommended vaccination schedules, including for tetanus prone wounds, refer to The Australian Immunisation Handbook of the NHMRC in Australia or the New Zealand Immunisation Handbook in New Zealand. ADT™ Booster is recommended for re-vaccination after an initial primary cour Leer el documento completo